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      A bibliometric analysis of the global research on biosimilars

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          Abstract

          Background

          Biosimilars could be a promising option to help decrease healthcare costs and expand access to treatment. There is no previous evidence of a global bibliometric analysis on biosimilars. Therefore, we aimed to assess the quantity and quality of worldwide biosimilars research.

          Methods

          We performed a bibliometric analysis using documents about biosimilars published until December 2016 in journals indexed in Scopus. We extracted the annual research, languages, countries, journals, authors, institutions, citation frequency, and the metrics of journals. The data were quantitatively and qualitatively analyzed using Microsoft Excel 2013. Additional information about authors' participation was obtained using the R-package Bibliometrix. Publication activity was adjusted for the countries by population size. Also, author co-citation analysis and a term co-occurrence analysis with the terms included in the title and abstract of publications was presented as network visualization maps using VOSviewer.

          Results

          A total of 2330 biosimilar-related documents identified in the Scopus database, most of them were articles (1452; 62.32%). The number of documents published had an exponential increased between 2004 and 2016 ( p < 0.001). The United States was the country with the highest production with 685 (29.40%) documents followed by Germany and UK with 293 (12.58%) and 248 (10.64%), respectively. Switzerland (11.05), Netherlands (5.85) and UK (3.83) showed the highest per capita ratio. The highest citation/article ratio were for the Netherlands (28.06), Spain (24.23), and France (20.11). Gabi Journal published 73 (3.13%) documents; both Biopharm International and Pharmaceutical Technology and Mabs, 41 (1.76%). Three out of top ten journals were Trade publications. Amgen Incorporated from the USA was the most prolific institution with 51 documents followed by Pfizer Inc. with 48. Terms about specific diseases and drugs were found in recent years, compared with terms such as legislation, structure, protein, dose and generic in the early years.

          Conclusions

          Research production and publication of documents on biosimilars are increasing. The majority of publications came from high-income countries. The trends in terminology use are according to state of the art in the topic, and reflects the interest in the utilization of biosimilars in diseases who are expected to obtain benefits of its use.

          Electronic supplementary material

          The online version of this article (10.1186/s40545-018-0133-2) contains supplementary material, which is available to authorized users.

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          Most cited references32

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          Bibliometrics: tracking research impact by selecting the appropriate metrics

          Traditionally, the success of a researcher is assessed by the number of publications he or she publishes in peer-reviewed, indexed, high impact journals. This essential yardstick, often referred to as the impact of a specific researcher, is assessed through the use of various metrics. While researchers may be acquainted with such matrices, many do not know how to use them to enhance their careers. In addition to these metrics, a number of other factors should be taken into consideration to objectively evaluate a scientist's profile as a researcher and academician. Moreover, each metric has its own limitations that need to be considered when selecting an appropriate metric for evaluation. This paper provides a broad overview of the wide array of metrics currently in use in academia and research. Popular metrics are discussed and defined, including traditional metrics and article-level metrics, some of which are applied to researchers for a greater understanding of a particular concept, including varicocele that is the thematic area of this Special Issue of Asian Journal of Andrology. We recommend the combined use of quantitative and qualitative evaluation using judiciously selected metrics for a more objective assessment of scholarly output and research impact.
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            Treatment with Biologicals in Rheumatoid Arthritis: An Overview

            Management and therapy of rheumatoid arthritis (RA) has been revolutionized by the development and approval of the first biological disease-modifying antirheumatic drugs (bDMARDs) targeting tumor necrosis factor (TNF) α at the end of the last century. Today, numerous efficacious agents with different modes of action are available and achievement of clinical remission or, at least, low disease activity is the target of therapy. Early therapeutic interventions aiming at a defined goal of therapy (treat to target) are supposed to halt inflammation, improving symptoms and signs, and preserving structural integrity of the joints in RA. Up to now, bDMARDs approved for therapy in RA include agents with five different modes of action: TNF inhibition, T cell co-stimulation blockade, IL-6 receptor inhibition, B cell depletion, and interleukin 1 inhibition. Furthermore, targeted synthetic DMARDs (tsDMARDs) inhibiting Janus kinase (JAK) and biosimilars also are approved for RA. The present review focuses on bDMARDs and tsDMARDS regarding similarities and possible drug-specific advantages in the treatment of RA. Furthermore, compounds not yet approved in RA and biosimilars are discussed. Following the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) recommendations, specific treatment of the disease will be discussed with respect to safety and efficacy. In particular, we discuss the question of favoring specific bDMARDs or tsDMARDs in the two settings of insufficient response to methotrexate and to the first bDMARD, respectively.
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              Patient attitudes and understanding about biosimilars: an international cross-sectional survey

              Objective To understand the levels of awareness, usage, and knowledge of biosimilars among patients, caregivers, and the general population in the US and the European Union; perceptions of biosimilars compared to originator biologics; perceived benefits and drawbacks of clinical trials; and whether advocacy groups impact patients’ willingness to try a biosimilar. Methods An international survey was conducted which contained up to 56 closed-ended (requiring yes/no or ranking answers) and open-ended questions, depending on the population assigned. The survey was divided into distinct sections, including medication-class awareness, usage, and knowledge about biologic and biosimilar therapies; perceptions of clinical trials; and involvement in advocacy groups. Interviews were conducted in adults categorized as: 1) diagnosed: patients with inflammatory bowel disease including Crohn’s disease and ulcerative colitis, rheumatoid arthritis, psoriasis, breast cancer, lung cancer, colorectal cancer, or non-Hodgkin’s lymphoma; 2) diagnosed advocacy: individuals with these diseases who participated in patient support groups; 3) caregiver: has a loved one with these conditions and is involved in medical decisions; 4) general population: aged 18–64 years, without these conditions. Statistical analyses among groups within a region (US or EU) used column proportions test with a 95% confidence interval. Results In all, 3,198 individuals responded. Awareness about biologic therapies was significantly higher in diagnosed, diagnosed advocacy, and caregiver groups (45%–78%) versus general population (27%; P<0.05). Across all groups, awareness of biosimilars was low; only 6% of the general population reported at least a general impression of biosimilars. Awareness was significantly higher in the diagnosed advocacy group (20%–30%; P<0.05). Gaps in knowledge about biosimilars included safety, efficacy, and access to these agents. Respondents had generally positive perceptions of clinical trials, although barriers to participation were identified. Conclusion An immediate need exists for patient education about biosimilars and clinical trials to ensure educated and informed decisions are made about biosimilar use.
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                Author and article information

                Contributors
                akram.hernandez.v@upch.pe
                christoper.alarconr20@gmail.com
                guido.bendezu.q@upch.pe
                dcomande@iecs.org.ar
                diego.rosselli@gmail.com
                Journal
                J Pharm Policy Pract
                J Pharm Policy Pract
                Journal of Pharmaceutical Policy and Practice
                BioMed Central (London )
                2052-3211
                27 March 2018
                27 March 2018
                2018
                : 11
                : 6
                Affiliations
                [1 ]GRID grid.441984.4, Universidad Privada del Norte, ; Lima, Peru
                [2 ]GRID grid.441904.c, Facultad de Medicina, , Universidad Ricardo Palma, ; Lima, Peru
                [3 ]ISNI 0000 0001 0673 9488, GRID grid.11100.31, Universidad Peruana Cayetano Heredia, ; Lima, Peru
                [4 ]ISNI 0000 0004 0439 4692, GRID grid.414661.0, Institute for Clinical Effectiveness and Health Policy (IECS), ; Buenos Aires, Argentina
                [5 ]ISNI 0000 0001 1033 6040, GRID grid.41312.35, Departamento de Epidemiología Clínica y Bioestadística, Facultad de Medicina, , Pontificia Universidad Javeriana, ; Bogotá, Colombia
                Author information
                http://orcid.org/0000-0003-1431-2526
                Article
                133
                10.1186/s40545-018-0133-2
                5870206
                fc2d6514-4601-47c7-981d-6c9d66c3b13b
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 20 November 2017
                : 5 March 2018
                Categories
                Research
                Custom metadata
                © The Author(s) 2018

                biosimilar pharmaceuticals,bibliometrics,biomedical research (source: mesh nlm)

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